Anti-reflux ureteral stents and methods

ABSTRACT

An anti-reflux ureteral stent includes an elongated member with a distal end having a first retention structure and a proximal end having a second retention structure. A lumen extends between the distal and proximal ends. The elongated member may include a valve near the proximal end and distal to the second retention structure. The valve may include one or more slits or windows tending to render the elongated member collapsible. The valve may include one or more protrusions to partially occlude the lumen. A protrusion, if present, may be shaped as a helical thread. The second retention structure may be shaped as a barb to engage a ureteral orifice in a bladder.

TECHNICAL FIELD

[0001] This invention generally relates to medical devices for drainageof fluids, and more specifically to anti-reflux medical devices fordrainage of fluids.

BACKGROUND INFORMATION

[0002] Drainage devices or stents may be used to treat or avoidobstructions in fluid passageways due to ureteral tumors that disruptthe flow of urine from the kidneys to the bladder. They also may be usedto strengthen a compromised vessel such as a ureteral wall. Ureteralstents typically are tubular in shape, terminating in two opposing ends:a kidney distal end and a bladder proximal end. One or both of the endsmay be curved in a pigtail or J-shape to prevent the migration of thestent due, for example, to physiological movements.

SUMMARY OF THE INVENTION

[0003] Stents may cause or contribute to significant patient discomfort.One problem associated with ureteral stents is bladder pain attributedto stent contact with the trigone area of the bladder, particularly whenthe stent extends through the ureteral orifice and into the bladder. Theregion known as the trigone or trigonum is a triangular-shaped regionlocated on the floor of the urinary bladder between the opening of theurethra in front and the two ureters at the sides. The trigone isbelieved to be particularly innervated and sensitive to the presence ofany foreign bodies such as stent members. Another problem associatedwith ureteral stents is flank pain caused by urine reflux that occurswhen urine travels from the bladder to the kidneys in response toretrograde pressure. Retrograde pressure occurs in the bladder whenattempting to void the bladder of urine, and may transmit urine or otherfluids up the stent to the kidney. The rigidity of even relatively softureteral stents may also irritate the intramural tunnel (the lower 1-2cm of the ureter prior to its entry into the bladder). In the absence ofa stent, the intramural tunnel closes during voiding of the bladder; thepresence of a stent may interfere with this closure, irritating theintramural tunnel and permitting urine reflux.

[0004] The present invention concerns a ureteral stent designed toreduce patient discomfort generally caused by stents contacting thetrigone or by urine flowing up the stent toward the kidney. Thus,increased comfort may be gained by reducing the size of the retentionstructure at the bladder (proximal) end of the stent. Patient discomfortcan be minimized by reducing the amount of contact with the trigone.Valves and other structures can minimize flank pain by interruptingurine backflow up the stent toward the kidney without preventingdrainage of urine from the kidney to the bladder. Modifying that portionof the stent residing in the intramural tunnel to render that portiondeformable or collapsible can ease closure of the intramural tunnelduring voiding of the bladder, reducing intramural tunnel irritation andurine reflux. In all aspects of the following invention descriptions,all members have a distal retention end structure, the purpose of whichis to prevent downward migration of the stent from kidney to bladder andmaintain the proximal retention structure to be as close to the ureteralorifice as possible.

[0005] In one aspect, the invention relates to a ureteral stentincluding an elongated member having a distal end with a first retentionstructure and a proximal end with a second retention structure. A lumenextends between the proximal and distal ends of the elongated member.The elongated member includes a valve positioned near the proximal end,but distal to the proximal retention structure. The valve is preferablybetween about one centimeter to about four centimeters (more preferablyat about two centimeters) from the proximal retention structure. Thedistance of the valve from the proximal retention structure is measuredfrom that portion of the proximal retention structure that, in use,contacts the ureteral orifice and restrains further movement of theelongated member towards the kidney; the distance is therefore thedistance from the valve to the ureteral orifice when the stent is inuse. Where applicable, the middle of the valve (e.g. the middle of aslit, window, etc.) is considered to be the position of the valve formeasuring purposes. The elongated member should be long enough such thatwhen the stent is in a human ureter, the distal end may reside in akidney and the proximal end in the bladder. The elongated memberpreferably has a plurality of openings permitting fluid access to thelumen.

[0006] The valve may include a slit or a window in a wall of theelongated member. The slit or window may be at least one centimeterlong. The valve may include a plurality of slits or windows. Forexample, the valve may include two windows, or three parallel slits.

[0007] The valve may also include a flap extending from a wall of theelongated member. For example, the valve may include at least two flapsextending proximally from the wall and positioned such that the flapsare in contact with one another, closing the valve, when fluid pressurefrom the proximal (bladder) end is greater than the pressure from thedistal (kidney) end. When fluid pressure from the distal end exceeds thepressure from the proximal end, the flaps separate, opening the valve.

[0008] The proximal retention structure may include a hydrophilicpolymer that expands upon hydration and may be shaped, for example, as acylinder. The hydrophilic polymer may be, for example, polyurethane,nylon, polycarbonate, poly(ethylene oxide), polyvinyl pyrrolidone,polyvinyl alcohol, poly(ethylene glycol), polyacrylamide,poly(hydroxyethylacrylate), or copolymers thereof.

[0009] In another embodiment, the invention relates to a ureteral stentincluding an elongated member having a distal end with a first retentionstructure, a proximal end with a second retention structure, and aninner surface defining a lumen between the distal and proximal ends. Oneor more protrusions extend from the inner surface into the lumen topartially occlude the lumen. The one or more protrusions are shaped andpositioned to introduce turbulence into urine flow from the proximal endduring voiding of the bladder when the distal end is in a kidney and theproximal end in a bladder, reducing urine reflux. The one or moreprotrusions permit urine flow from the kidney to the bladder at othertimes. The one or more protrusions may be rigid, and preferably reducethe hydraulic radius by a factor of at least two, three, or four.

[0010] In yet another embodiment, the invention relates to a ureteralstent including an elongated member having a distal end with a firstretention structure, a proximal end with a second retention structure,and an inner surface defining a lumen between the distal and proximalends. A portion of the inner surface between the distal and proximalends includes a helical thread having a height extending into the lumen.The height of a proximal portion of the thread may exceed the height ofa distal portion of the thread. Preferably, the lumen has asubstantially circular cross-section and the height of a proximalportion of the thread is greater than the radius of the lumen. Thehelical thread may include a proximally-facing wall forming a 90 degreeangle with the inner surface; the angle may be sharp-edged orround-edged. In a preferred embodiment, a proximally-facing wall and asecond wall of the helical thread form a sharp-edged angle no greaterthan about 90 degrees. The helical thread may include a distally-facingwall forming an angle of no more than 90 degrees with the inner surface.

[0011] In another aspect, the invention relates to a method of promotingureteral urine flow. The method includes the steps of providing aureteral stent and introducing it into a ureter. The stent has a distalend with a retention structure and a proximal end with a barb. The stentis introduced into the ureter such that the distal end of the stent isin a kidney and the proximal end is in the bladder. The barb engages theureteral orifice of the ureter to prevent distal migration of theureteral stent out of the bladder.

[0012] In another embodiment, the invention relates to a method ofpromoting ureteral urine flow without undue bladder irritation. Themethod includes the steps of providing a ureteral stent and introducingit into a ureter. The stent has a distal end with a first retentionstructure and a proximal end with a second retention structure. Thestent is introduced such that the distal end of the stent is in a kidneyand the proximal end in the bladder. The proximal end of the ureteralstent extends less than two centimeters into the bladder.

[0013] In yet another embodiment, the invention relates to a method ofpromoting ureteral urine flow while minimizing intramural tunnelirritation. The method includes the steps of providing a ureteral stentand introducing it into a ureter. The stent has a compressible portionbetween a distal end with a first retention structure and a proximal endwith a second retention structure. The proximal end may be positioned ina bladder, and the distal end may be positioned in a kidney. The stentis preferably positioned in a patient such that the compressible portionis in an intramural tunnel, permitting compression of the stent by theintramural tunnel during voiding of the bladder.

[0014] In still another embodiment, the invention includes a method forpromoting ureteral urine flow from a kidney to a bladder. The methodincludes the steps of providing a ureteral stent and introducing it intoa ureter. The ureteral stent includes an elongated member having adistal end with a first retention structure and a proximal end with asecond retention structure. The elongated member also has an innersurface defining a lumen between the distal and proximal ends. The innersurface has one or more protrusions that extend into and partiallyocclude the lumen. The one or more protrusions disrupt urine flow fromthe bladder during voiding of the bladder, thereby reducing reflux,while permitting urine flow from the kidney to the bladder at othertimes. The stent is preferably positioned in a patient with the distalend in a kidney and the proximal end in the bladder.

[0015] In a preferred embodiment, the invention includes a method ofpromoting ureteral urine flow from a kidney to a bladder. The methodincludes the steps of providing a ureteral stent and introducing it intoa ureter. The stent includes an elongated member having a distal endwith a first retention structure and a proximal end with a secondretention structure. The elongated member also has an inner surfacedefining a lumen between the distal and proximal ends. A portion of theinner surface includes a helical thread having a height extending intothe lumen. A height of a proximal portion of the thread is greater thanthe height of a distal portion of the thread. The stent may bepositioned with the distal end in a kidney, and may be positioned with aproximal end in the bladder. The stent is preferably positioned suchthat the height of the thread is greater in a portion of the threadtoward the proximal end of the stent, discouraging urine reflux from thebladder to the kidney and permitting urine drainage from the kidney tothe bladder.

[0016] The foregoing and other aspects, embodiments, features, andadvantages of the invention will become apparent from the followingdescription, figures, and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The drawings are not necessarily to scale, emphasis insteadgenerally being placed upon illustrating the principles of theinvention.

[0018]FIG. 1A depicts an exemplary embodiment of a ureteral stent of theinvention with a slit valve in the elongated member and a pigtail at theproximal end; FIG. 1B depicts the proximal portion of another exemplaryembodiment with a plurality of slits in the elongated member and a barbat the proximal end.

[0019] FIGS. 2A-2D depict exemplary ureteral stents with window valves.

[0020]FIG. 3 depicts a pair of the ureteral stents of FIG. 2A implantedin a pair of mammalian ureters.

[0021]FIG. 4 depicts an exemplay ureteral stent with a slit valve in atapered portion of the stent.

[0022] FIGS. 5A-B depict exemplary ureteral stents with flap valves.FIG. 5A depicts a stent with an internal flap valve and with a pigtailas a proximal retention structure; FIG. 5B depicts a proximal portion ofa stent with large windows and a flap valve.

[0023]FIG. 6 depicts protrusions in a ureteral stent lumen.

[0024]FIG. 7 depicts a helical thread protruding into a ureteral stentlumen.

[0025] FIGS. 8A-8E depict ureteral stents having an expandable retentionstructure at the proximal end.

DESCRIPTION

[0026] This invention generally concerns a ureteral stent thatsignificantly reduces discomfort to a patient when positioned within apatient's ureter. The devices and methods of the present inventionincrease patient comfort by minimizing the degree of contact of thedevice with the trigone region, by providing a deformable or collapsiblestent portion in the intramural tunnel, and/or by reducing oreliminating reflux of liquid to the kidneys from the bladder.

[0027] Referring to FIG. 1A, ureteral stent 10 includes elongated member12 having distal end 14 with first retention structure 16, depicted as afirst pigtail. Elongated member 12 also includes proximal end 18 withsecond retention structure 20, depicted as a second pigtail. As will befurther elaborated below, first retention structure 16 and secondretention structure 20 may instead have other shapes suitable tostabilize the stent within the ureter, such as a hook or J-shape, barbs,protrusions, and the like. A lumen (not shown) extends between proximalend 18 and distal end 14; ureteral stent 10 also generally includes aplurality of openings (not shown) providing fluid access to the lumen.The cross-sectional geometry of the stent and the lumen may be any shapethat allows liquid flow including, for example, round, oblong,elliptical, hexagonal, D-shaped, crescent-shaped and square.

[0028] The ureteral stent may be formed of a biocompatible plastic orpolymer such as ethylene vinyl acetate (EVA), polytetrafluoroethylene(PTFE), silicone polyurethane, polyamide, polyurethane plastics,polyethylene plastics, and other thermoplastics and block copolymersthereof, for example. The polymer may have a Shore hardness betweenabout 60A and about 85A, or alternately between 20 Shore D and 65 ShoreD.

[0029] The ureteral stents may have walls of constant or varyingthickness. Preferably, portions of the walls near the distal end orsufficiently thick to be kink-resistant despite constriction or othermanipulation of the stent due to enlargement of tissue surrounding it orperistaltic motions, and during insertion and removal of the device intoand out of the body. A kink-resistant stent wall has an annular wallthat does not collapse upon itself upon radial or lateral pressure ofthe surrounding body tissues when positioned to drain a body cavity of amammal or upon longitudinal pressure exerted during insertion of thestent. A wall may be rendered sufficiently kink-resistant by varying thethickness of the wall of the stent; appropriate wall thickness dependson the softness or sturdiness of the material used to manufacture thestent. For example, a wall thickness of from about 0.008 inches to about0.03 inches may be used with materials such as silicone, EVA, PTFE,polyurethane plastics, polyethylene plastics, and copolymers thereof.The inner diameter may be between about 0.035 inches to about 0.12inches, preferably between about 0.035 inches and 0.075 inches, and morepreferably is about 0.06 inches. The outer diameter may be between about0.05 inches and about 0.12 inches, preferably between about 0.05 inchesand about 0.1 inches, and more preferably is about 0.09 inches.

[0030] In the preferred embodiment shown in FIG. 1A, valve 22 is locatedon the elongated member near proximal end 18 but distal to secondretention structure 20. Valve 22 preferably includes a deformable wallwith at least one longitudinal slit 24 which traverses a wall ofelongated member 12 and extends from the exterior surface of the wall tothe interior surface bordering the lumen. Slit 24, if present, ispreferably at least one centimeter long, and is more preferably abouttwo centimeters long. As shown in FIG. 1B, valve 22 may alternativelyinclude a plurality (e.g. three or more) of parallel slits 24. Valve 22is preferably positioned at a distance from second retention structure20 by about zero (juxtaposition) to about four centimeters.

[0031] Referring to FIGS. 2A-D, valve 22 may instead include adeformable wall with one or more (e.g. two) windows 28 traversing thewall of elongated hollow member 12. The window or windows 28 arepreferably at least one centimeter long and are more preferably abouttwo centimeters long. proximal end 18 of elongated member 12 may includea second retention structure. The retention structure may include one ormore barbs 20′ (FIGS. 2A, 2B, 2D); a structure 20″ having an outerdimension W, perpendicular to the longitudinal axis of elongated member12, that is greater than the outer diameter of the elongated member 12(FIG. 2C, shown with rounded edges), or a pigtail as in FIG. 1A.Furthermore, elongated hollow member 12 may be twisted about itslongitudinal axis in the vicinity of valve 22 as shown in FIG. 2D,facilitating fluid flow through the window or windows 28 and potentiallyreducing the effective diameter of that portion of elongated hollowmember 12.

[0032] A second retention structure 20 may be formed by skivingelongated member 12 to form a barb 20′ (FIGS. 2A, 2B, 2D), or by moldinga barb from, for example, a silicone flap. A barb, if present, ispreferably no more than about 4 mm long.

[0033] In use, ureteral stent 10 is inserted into a mammalian ureter 30such that distal end 14 of elongated member 12 is in a kidney 32 andproximal end 18 is in bladder 34, as shown in FIG. 3. Ureteral stent 10may be inserted with the aid of a guidewire and a pusher through theurethra (not shown) and bladder 34 to the final position in ureter 30.In some embodiments, first retention structure 16 and second retentionstructure 20 are formed from a material that reforms its structure afterhaving its shape distorted. This property of the material allows firstretention structure 16 and second retention structure 20 to be collapsedor straightened during insertion of the stent into the body, yetallowing the structures to reform into their original shapes afterplacement of ureteral stent 10 in ureter 30. The guidewire or a cannulamay be used to temporarily straighten the retention structure duringinsertion and placement of ureteral stent 10. Ureteral stent 10 may alsobe inserted into position by use of an endoscope, a ureteroscope, or acytoscope, for example.

[0034] If proximal end 18 includes a second retention structure 20shaped as a barb 20′ (FIGS. 2A, 2B, 2D), the barb preferably engagesureteral orifice 36 to prevent ureteral stent 10 from migrating distallyout of bladder 34. A cannula, sleeve, or cytoscope is preferably used tocover the barb during insertion of ureteral stent 10 into the patient.Desirably, as shown in FIG. 3, this configuration minimizes the amountof material from the ureteral stent 10 that resides in bladder 34 ascompared to, for example, the amount of material from the firstretention structure 16 shown residing in kidney 32. Thus, the potentialfor irritation to the trigone region 38 of bladder 34 is reduced. Valve22 is preferably placed within intramural tunnel 40 of ureter 30. Inembodiments where valve 22 includes window or windows 28, as shown inFIG. 3, or a slit or other modification reducing the resistance tokinking of the wall of that portion of elongated member 12, intramuraltunnel 40 closes around the outer surface of the valve, activating it bycollapsing its wall such that opposite walls contact one another andobstruct the lumen, preventing urine reflux during voiding of bladder34. Thus, the positioning of valve 22 within intramural tunnel 40minimizes irritation to intramural tunnel 40, reducing patientdiscomfort. To further reduce irritation to intramural tunnel 40, theportion of elongated member 12 intended for placement in intramuraltunnel 40 may also be tapered (e.g. to a size of about 5 French) asshown in FIG. 4.

[0035] As shown in FIGS. 5A-5B, valve 22 may include at least one flap42 (e.g. a pair of flaps 42, as shown) extending inward from an internalwall of elongated member 12 to better reduce urine reflux. The flap (orflaps) 42 contact a wall of elongated member 12 (and/or each other) toresist fluid flow from the bladder. The flap or flaps 42 neverthelessopen to permit fluid drainage from the kidney.

[0036] Urine reflux may also be minimized a valve that includes one ormore protrusions 44 as shown in FIG. 6. Protrusion(s) 44 extend from theinner surface of elongated member 12 into the lumen, partially occludingthe lumen. Protrusion(s) 44 introduce turbulence into urine flow towardkidney 32 during voiding of bladder 34. Urine in bladder 34 is at arelatively high pressure during voiding, and would travel at relativelyhigh speed toward a kidney through an open ureteral stent, in theabsence of a valve, protrusion, or other mechanism to retard the urinereflux. Protrusion(s) 44 in ureteral stent 10 act as one or more “speedbumps” to absorb or deflect the energy or velocity of high pressureurine, slowing and (thereby) reducing urine reflux. Generally,protrusion(s) 44 increase(s) turbulence in refluxing urine, dissipatingthe energy of the urine flow. Protrusion(s) 44, which are preferablyrigid, nevertheless do not preclude the normal flow of urine from thekidney to the bladder. Thus, in embodiments where a protrusion 44 spansthe lumen of elongated member 12, one or more gaps or pores inprotrusion 44 permit passage of urine therethrough. Protrusion(s) 44reduce(s) the hydraulic radius of a portion of elongated member 12.Preferably, the protrusions are positioned and shaped to reduce thehydraulic radius by at least a factor of two, and more preferably by atleast a factor of four. A discussion of factors determining thehydraulic radius of a channel and the effects of various types ofprotrusions on hydraulic radius may be found in Chapter 4 of Lindeburg,P. E., Engineer In Training Review Manual, Professional Publications:San Carlos, Calif. (1982), herein incorporated by reference.

[0037] Ureteral stent 10 may include a protrusion 44′ shaped as ahelical thread like an Archimedes' screw as shown in FIG. 7. Protrusion44′ need not extend throughout the length of ureteral stent 10; indeed,protrusion 44′ is preferably limited to only a portion (e.g. a 1-3 cmportion) of ureteral stent 10. Preferably, the height of thethread/protrusion is varied along its length such that a portion ofprotrusion 44′ closer to proximal end 18 of elongated member 12 has aheight into the lumen that is greater than the height of a more distalportion of the protrusion 44′. In an embodiment where the lumen has asubstantially circular cross-section, the height of a proximal portionof protrusion 44′ is preferably greater than a radius of the lumen.Thus, fluid passing through the lumen necessarily follows the helicalthreads, because no line-of-sight fluid path is available. Generally,the sides of the protrusion form right and/or obtuse angles with theinner surface of the elongated member; the angles may be sharp orrounded. In one embodiment, a proximal surface 45 of protrusion 44′forms a right angle with the inner surface of elongated member 12. Inanother embodiment, a distal surface 47 of protrusion 44′ forms anobtuse angle α with the inner surface of the elongated member 12.

[0038] Ureteral stent 10 with protrusion(s) 44 or 44′ may be formed, forexample, by injection molding the protrusion(s) or by lamination over aninsert. The protrusion(s) may be formed of a metal or a polymer.

[0039] In preferred embodiments shown in FIGS. 8A-8E, second retentionstructure 20 includes a hydrophilic swellable polymer that expands uponhydration. Thus, as shown in FIGS. 8A and 8C, prior to hydration, secondretention structure 20 may be as small as 5 to 9 French, ensuring thatureteral stent 10 can be delivered using standard stent deliveryequipment (e.g. cytoscopes). Upon insertion of ureteral stent 10 into aureter 30 (FIGS. 8B, 8D, and 8E), exposure of the hydrophilic polymer tomoisture from urine causes significant hydration of the hydrophilicpolymer, leading to expansion of second retention structure 20. Secondretention structure 20 thus becomes larger than the opening of ureteralorifice 36. Thus, upon expansion of second retention structure 20,proximal end 18 of ureteral stent 10 is necessarily retained withinbladder 34. Generally, expansion is substantially complete within about1-2 hours. Expansion of second retention structure 20 also dramaticallysoftens it from, for example, about 65 D to about 35-40 A. Thissoftening should reduce irritation to trigone region 38 of bladder 34(FIG. 8E), and facilitates stent extraction, as the material easilydeforms through the urethra upon removal.

[0040] Despite the post-hydration expansion of second retentionstructure 20 in the preferred ureteral stent 10 shown in FIGS. 8A-8E,second retention structure 20 remains smaller in mass and surface areathan a conventional stent bladder coil. Second retention structure 20may be shaped as a cylinder, for example, or in any other shape, so longas, after expansion, second retention structure 20 is larger than theopening of ureteral orifice 36 in a dimension permitting retention ofsecond retention structure 20 at ureteral orifice 36.

[0041] A hydrophilic swellable polymer, if present, may be any polymercapable of sufficient expansion upon hydration, such as, reticulated orcrosslinked polymers derived from any of polyurethane, nylon,polycarbonate, poly(ethylene oxide), polyvinyl pyrrolidone, polyvinylalcohol, poly(ethylene glycol), polyacrylamide,poly(hydroxyethylacrylate), and copolymers thereof. Generally, hydrationexpands the swellable polymer by at least a factor of 1.2. Preferably,outer diameter of the hydrophilic polymer expands at least a factor of1.5 upon hydration; more preferably, the outer diameter expands by atleast a factor of 2.0 upon hydration. Thus, for example, the outerdiameter of second retention structure 20 may be about 0.08 inches priorto hydration, and about 0.16 inches or more after hydration. Usefulhydrophilic polymers and their application in ureteral stents can befound, for example, in U.S. Pat. Nos. 5,599,291; and 5,964,744, both ofwhich are herein incorporated by reference in their entirety.

[0042] An expandable second retention structure 20 may be joined to theremainder of ureteral stent 10 through a plurality (e.g., 2-8) ofconnectors 46, as shown in FIGS. 8A, 8B, and 8E. In this embodiment,ureteral stent 10 transitions from a cylindrical extrusion to a seriesof solid-core polymer connectors 46 about 5 cm from the ureteralorifice. The cylindrical extrusion typically has an outer diameter of5-8 French and an inner diameter of 0.04″-0.08″; the connectors 46typically have outer diameters of about 0.01″-0.04.″ Connectors 46 maybe attached to the remainder of ureteral stent 10 by a thermalattachment/lamination process, in which case connectors 46 should bethermally compatible with the hydrophilic polymer of second retentionstructure 20, and more preferably is formed of the same base polymer.Alternatively, connectors 46 may be formed by excising or otherwiseremoving material from a portion of a cylindrical extrusion, or may beincorporated into ureteral stent 10 using coextrusion techniques.

[0043] As shown in FIG. 8E, connectors 46 provide a collapsible proximalureter/intramural tunnel section to reduce intramural tunnel irritationwhen compared to a conventional cylindrical stent portion. Because theintramural tunnel compresses about connectors 46 during voiding ofbladder 34, urine reflux is diminished by the reduction in the“free-volume” available in the distal ureter.

[0044] Alternatively, second retention structure 20 may be attacheddirectly to the remainder of ureteral stent 10 as shown in FIGS. 8C-8D,through thermal attachment procedures, for example. Even in the absenceof connectors 46, second retention structure 20 is free to expand andfunction as intended in this alternative embodiment, preventing upwardstent migration toward kidney 32 and providing a relatively soft portionin bladder 34 to reduce irritation to trigone region 38.

[0045] Elements of the ureteral stents of the present invention may beattached to each other by any of a variety of methods including, forexample, the use of adhesives, heat welding, mechanical fasteners,and/or by inserting one component into the internal diameter of another.For example, two elements may be formed, one with a female end and onewith a male end with teeth stamped therein, so that when the male end isinserted into the female end, it is locked or snap-fit into positionwith the teeth. Retention structures, such as pigtails, hooks, barbs,and/or lips, may be made of memory-shaped material so that thestructures may be temporarily straightened for insertion along aguidewire and thereafter returned to their “normal” shapes.

[0046] Having thus described certain embodiments of the presentinvention, various alterations, modifications, and improvements will beapparent to those of ordinary skill. Such alterations, modifications,and improvements are intended to be within the spirit and scope of theinvention. Accordingly, the foregoing description of illustrativeembodiments of the invention is not intended to be limiting.

What is claimed is:
 1. A ureteral stent comprising: an elongated memberhaving a distal end comprising a first retention structure and aproximal end comprising a second retention structure and defining alumen extending therebetween, the elongated member comprising a valvedistal to the second retention structure.
 2. The ureteral stent of claim1, wherein the valve comprises a slit defined by a wall of the elongatedmember.
 3. The ureteral stent of claim 2, wherein the slit is alongitudinal slit.
 4. The ureteral stent of claim 1, wherein the valvecomprises at least three parallel slits defined by a wall of theelongated member.
 5. The ureteral stent of claim 1, wherein the valvecomprises a window defined by a wall of the elongated member.
 6. Theureteral stent of claim 5, wherein the valve comprises two windowsdefined by a wall of the elongated member.
 7. The ureteral stent ofclaim 1, wherein the valve comprises a flap extending from a wall of theelongated member.
 8. The ureteral stent of claim 7, wherein the valvecomprises at least two flaps extending from a wall of the elongatedmember and positioned such that the flaps are in contact with each otherwhen fluid pressure from the proximal end exceeds fluid pressure fromthe distal end, closing the valve, and are separated when fluid pressurefrom the distal end exceeds fluid pressure from the proximal end,opening the valve.
 9. The ureteral stent of claim 1, wherein the secondretention structure comprises a barb.
 10. The ureteral stent of claim 1,wherein the second retention structure comprises a hydrophilic polymerthat expands upon hydration.
 11. The ureteral stent of claim 10, whereinthe hydrophilic polymer is selected from the group consisting ofpolyurethane, nylon, polycarbonate, polyethylene, poly(ethylene oxide),polyvinyl pyrrolidone, polyvinyl alcohol, poly(ethylene glycol),polyacrylamide, poly(hydroxyethylacrylate), and copolymers thereof. 12.The ureteral stent of claim 1, wherein the valve is disposed at adistance between about one centimeter to about four centimeters from thesecond retention structure.
 13. The ureteral stent of claim 1, whereinthe elongated member has a length sufficient to permit the distal end toreside in a kidney and the proximal end to reside in a bladder while theureteral stent is in a human ureter.
 14. The ureteral stent of claim 1,wherein the elongated member further defines a plurality of openingspermitting fluid access to the lumen.
 15. A ureteral stent comprising:an elongated member having a distal end comprising a first retentionstructure and a proximal end comprising a second retention structure,the elongated member having an inner surface defining a lumen betweenthe distal end and the proximal end; and one or more protrusionsextending from the inner surface into the lumen to partially occlude thelumen, wherein the one or more protrusions are shaped and positioned tointroduce turbulence into urine flow from the proximal end duringvoiding of a bladder when the distal end is disposed in a kidney and theproximal end is disposed in the bladder.
 16. The ureteral stent of claim15, wherein the one or more protrusions reduce the hydraulic radius byat least a factor of two.
 17. A ureteral stent comprising: an elongatedmember having a distal end comprising a first retention structure and aproximal end comprising a second retention structure, the elongatedmember having an inner surface defining a lumen between the distal endand the proximal end, wherein a portion of the inner surface between thedistal end and the proximal end comprises a helical thread having aheight extending into the lumen.
 18. The ureteral stent of claim 17,wherein the height of a proximal portion of the helical thread isgreater than the height of a distal portion of the helical thread. 19.The ureteral stent of claim 18, wherein the lumen has a substantiallycircular cross-section, and wherein the height of the proximal portionof the helical thread is greater than a radius of the lumen.
 20. Theureteral stent of claim 17, wherein the helical thread comprises aproximally-facing wall forming a 90 degree angle with the inner surface.21. The ureteral stent of claim 17, wherein a proximally-facing wall ofthe helical thread and a second wall of the helical thread form asharp-edged angle no greater than about 90 degrees.
 22. The ureteralstent of claim 17, wherein the helical thread comprises adistally-facing wall forming an angle of more than 90 degrees with theinner surface.
 23. A method of promoting ureteral urine flow, the methodcomprising the steps of: providing a ureteral stent having a distal endcomprising a retention structure and a proximal end comprising a barb;and introducing the ureteral stent into a ureter having a ureteralorifice in a bladder such that the distal end of the ureteral stent isin a kidney and the proximal end is in the bladder, the barb of theproximal end engaging the ureteral orifice of the ureter to preventdistal migration of the ureteral stent out of the bladder.
 24. A methodof promoting ureteral urine flow without undue bladder irritation, themethod comprising the steps of: providing a ureteral stent having adistal end comprising a first retention structure and a proximal endcomprising a second retention structure; and introducing the ureteralstent into a ureter such that the distal end of the ureteral stent is ina kidney and the proximal end of the ureteral stent is in a bladder,wherein the proximal end of the ureteral stent extends less than twocentimeters into the bladder.
 25. A method of promoting ureteral urineflow without undue intramural tunnel irritation, the method comprisingthe steps of: providing a ureteral stent having a distal end comprisinga first retention structure, a proximal end comprising a secondretention structure, and a compressible portion therebetween; andintroducing the ureteral stent into a ureter.
 26. The method of claim25, wherein the ureteral stent is positioned in the ureter such that thecompressible portion is in an intramural tunnel, permitting compressionof the stent by the intramural tunnel.
 27. A method of promotingureteral urine flow from a kidney to a bladder, the method comprisingthe steps of: providing a ureteral stent comprising an elongated memberhaving a distal end comprising a first retention structure and aproximal end comprising a second retention structure, the elongatedmember having an inner surface defining a lumen between the distal endand the proximal end, the inner surface comprising one or moreprotrusions extending into and partially occluding the lumen;introducing the ureteral stent into a ureter; and disrupting urine flowfrom the bladder to the kidney during voiding of the bladder throughpartial occlusion of the lumen, thereby reducing reflux.
 28. A method ofpromoting ureteral urine flow from a kidney to a bladder, the methodcomprising the steps of: providing a ureteral stent comprising anelongated member having a distal end comprising a first retentionstructure and a proximal end comprising a second retention structure,the elongated member having an inner surface defining a lumen betweenthe distal end and the proximal end, a portion of the inner surfacecomprising a helical thread having a height extending into the lumen,and wherein the height of a proximal portion of the helical thread isgreater than the height of a distal portion of the helical thread;introducing the ureteral stent into a ureter; and positioning thehelical thread to reduce urine flow from the bladder to the kidneyduring voiding of the bladder, thereby reducing reflux.
 29. The methodof claim 28, wherein the ureteral stent is positioned such that theheight of the helical thread is greater in a portion of the threadtoward the bladder, thereby discouraging reflux of urine from thebladder to the kidney and permitting drainage of urine from the kidneyto the bladder.